BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 6101122 · Received November 14, 2016

    Report

    Report Number
    9611109-2016-00806
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    August 29, 2016
    Report Date
    August 29, 2016
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S5 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO REPRODUCE THE REPORTED ISSUE AND REPLACED THE TOUCH SCREEN. SUBSEQUENT TESTING FOUND NO FURTHER ISSUES AND THE DEVICE WAS RETURNED TO SERVICE. THE REPLACED DEVICES WERE DISCARDED BY THE CUSTOMER. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP WAS UNRESPONSIVE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750300 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 10-85-00

    Patients

    Seq Age Sex Outcome Treatment
    1